Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914…
Reason CGMP Deviations: Products not manufactured under current good manufacturing practices.
Reason Failed Dissolution Specifications
Reason CGMP Deviations
Reason cGMP deviations: Lots recalled were not manufactured in conformance with the FDA-approved manufacturing process for Auryxia.
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